Associate Director, Clinical Development
Job Description
**Associate Director, Clinical Development**
**Los Angeles, CA**
**Our Values**
· Integrity
· Intelligence
· Initiative
**What You Will Do**
– Lead drafting of clinical trial protocols for new indications
– Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access and value input into the development program(s)
– Interpret and communicate clinical trial data
– Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings
– Identify new clinical research opportunities
**What We Look For**
– Multi-year experience designing clinical trials and drafting protocols for US FDA
– In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials in all phases of development, especially Ph1b and 2/3 registrational trials
– Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
– Prior experience of regulatory interactions, authoring filing IND or BLA experience
– MD (or equivalent), PhD, PharmD or other Bachelors/higher degree
**Who we are …**
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a global leader in AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a “digital filter” that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a potentially registrational design. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA.
